Clinical trials: Psilocybin
Posttraumatic Stress Disorder
Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD).
- Trial name
- PAM-VET (NCT06989957)
- Testing
- Psilocybin, MDMA
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins University
Anxiety and Depression
Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults
To investigate the efficacy of a 16 week treatment with PSIL428 patient reported anxiety levels in otherwise healthy individuals suffering from depression and or anxiety symptoms.
- Trial name
- NCT04989972
- Testing
- PSIL428, Oyster mushroom
- Where
- Jamaica
- Sponsor
- Wake Network, Inc.
Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI
Psilocybin Microdosing on Cognition, Mood and Quality of Life
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo.
- Trial name
- NCT07449351
- Testing
- Psliocybin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yale University
Healthy
Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects
4-bromo-2,5-dimethoxyphenethylamine (2C-B) is a psychoactive substance with reportedly similar acute effects to both the prototypical empathogen 3,4-methylenedioxymethamphetamine (MDMA, Ecstasy) and the classic psychedelic…
- Trial name
- 2C-B (NCT05523401)
- Testing
- 4-bromo-2,5-dimethoxyphenethylamine (10 mg), 4-bromo-2,5-dimethoxyphenethylamine (20 mg), 4-bromo-2,5-dimethoxyphenethylamine (30 mg)
- Where
- Switzerland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Psilocybin
Precision Functional Brain Mapping in Psilocybin
This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain networks in healthy adults.
- Trial name
- Psilocybin PFM (NCT04501653)
- Testing
- Psilocybin, Methylphenidate
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Major Depressive Diorder
RCT of Psilocybin-assisted CBT for Depression
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2)…
- Trial name
- NCT07281352
- Testing
- Psilocybin (drug), cognitive behavioral therapy, Minimal supportive therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, Los Angeles
Alzheimer's Disease
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking.
- Trial name
- NCT07721467
- Testing
- Psilocybin, Cognitive Training
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Alcohol-Related Disorders, Depressive Disorder
Psilocybin in Alcohol Use Disorder With Comorbid Depression
Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment.
- Conditions
- Alcohol-Related Disorders, Depressive Disorder, Addiction
- Trial name
- PAD (NCT06235411)
- Testing
- Psilocybin therapy, Inactive Psilocybin therapy, Electroencephalogram
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Major Depressive Disorder
Psilocybin-assisted CBT for Depression
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2)…
- Trial name
- NCT05227612
- Testing
- Psilocybin, Cognitive behavioral therapy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of California, Los Angeles
Depression, Anxiety, Distress, Emotional
PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL)
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients…
- Trial name
- NCT04754061
- Testing
- Psilocybin
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Ottawa Hospital Research Institute
Post-Traumatic Headache
Effects of Psilocybin in Concussion Headache
The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days…
- Trial name
- NCT03806985
- Testing
- Low Dose Psilocybin, High Dose Psilocybin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Yale University
Alcohol Use Disorder (AUD), PTSD
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for…
- Trial name
- Psi-PS (NCT06853912)
- Testing
- Psilocybin 25 mg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Nathan Brashares Sackett
Treatment-resistant Depression
Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD).
- Trial name
- EPIsoDE (NCT04670081)
- Testing
- Psilocybin, Nicotinamide
- Where
- 2 sites in Germany
- Volunteers
- 144 people
- Sponsor
- Central Institute of Mental Health, Mannheim
Depression
Investigation to Understand and Optimize Psilocybin
This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression.
- Trial name
- OPTIMIZE (NCT06512194)
- Testing
- Psilocybin, Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Charles Raison
Depression - Major Depressive Disorder, Anhedonia
Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1.
- Trial name
- NCT07490353
- Testing
- Psilocybin (Usona Institute), Risperidone 1 MG, MRI
- Where
- Austria
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Alcohol Use Disorder
Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder
Twenty participants, age 18 or older, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for moderate to severe Alcohol Use Disorder will be randomized to open-label psilocybin (25 mg) therapy with…
- Trial name
- NCT04410913
- Testing
- Psilocybin plus Visual Healing Set and Setting, Psilocybin plus Standard Set and Setting
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Keith Heinzerling
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain.
- Trial name
- NCT05506982
- Testing
- Psilocybin, Psychotherapy, Quality-of-Life Assessment
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Emory University
Persisting Symptoms After Concussion
Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms…
- Trial name
- PatACT (NCT06615908)
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Calgary
Healthy Volunteer
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple…
- Trial name
- NCT07050368
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Opioid Use Disorder
Wellcome Leap Psilocybin for OUD
Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical…
- Trial name
- NCT06786325
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Anna Rose Childress, Ph.D.